金莲花软胶囊治疗急性扁桃体炎(外感风热证)的多中心临床研究

Multicenter clinical research to treat acute upper tonsillitis(exogenous windheat syndrome) with Jinlianhua Soft Capsule

目的评价金莲花软胶囊治疗急性扁桃体炎(外感风热证)的有效性和安全性。方法采用随机、双盲双模拟、阳性药平行对照、多中心临床研究方法,共纳入144例患者,按照3∶1的比例随机分为试验组108例和对照组36例。试验组给予金莲花软胶囊(2粒/次,3次/d)+冬凌草胶囊模拟剂治疗(3粒/次,3次/d);对照组给予冬凌草胶囊(3粒/次,3次/d)+金莲花软胶囊模拟剂治疗(2粒/次,3次/d),疗程均7 d。主要疗效指标为疾病综合疗效,次要指标为单项症状疗效、咽痛消失时间,安全性指标为不良事件及不良反应发生率。结果两组疾病综合疗效总有效率、愈显率比较差异均有统计学意义,其中试验组总有效率明显高于对照组(96.30%vs 80.56%,P<0.05),愈显率试验组明显高于对照组(86.11%vs61.11%,P<0.05)。咽痛或吞咽痛、咽干灼热的总有效率、愈显率,以及咽黏膜或悬雍垂红肿愈显率,且试验组均高于对照组,两组间比较差异均有统计学意义(P<0.05)。试验组中位消失时间略短于对照组(144 h vs 162 h),但是组间比较差异没有统计学意义(P>0.05)。研究期间两组不良事件及不良反应发生率比较,差异均无统计学意义。结论金莲花软胶囊治疗急性扁桃体炎(外感风热证)疗效确切,安全性较好,具有较好的临床应用价值。

Objective Evaluate the efficacy and safety of Jinlianhua Soft Capsule in the treatment of acute tonsillitis(exogenous wind-heat syndrome). Methods A randomized, double-blind, double-simulation, positive parallel control, multicenter clinical trial design method was used. A total of 144 patients were enrolled and randomized to an experimental group of 108 patients and a control group of 36 patients at a 3 : 1 ratio. The experimental group was treated with Jinlianhua Soft Capsule(2 capsules/d, tid) plus Donglingcao Capsule Simulator(3 capsules/d, tid), and control group was treated with Donglingcao Capsule(3 capsules/d, tid) plus Jinlianhua Soft Capsule Simulator(2 capsules/d, tid) for 7 days. The primary end point was the comprehensive curative effect of disease. Secondary end points were single symptom efficacy and disappearance time of pharyngeal pain. Meanwhile, the incidence of adverse events/adverse reactions, as safety indexes, were monitored. Results The total effective rate of experimental group was significantly higher than that of control group(96.30% vs 80.56%, P < 0.05). The effective rate of experimental group was significantly higher than that of control group(86.11% vs 61.11%, P < 0.05). In TCM single symptom aspect, the total effective rate and obvious curative rate of pharyngeal pain/swallowing pain and pharyngeal dryness and burning, as well as obvious curative rate of pharyngeal mucosa/uvula redness and swelling, there were statistically significant differences between the two groups(P < 0.05),experimental group was higher than control group. Meanwhile, the difference between experimental group and control group in median disappearance time of sore throat(144 h vs 162 h, P < 0.5) was not observed. There was no difference in adverse events and adverse reactions between two groups during the study period. Conclusion Jinlianhua Soft Capsule was effective in treating acute tonsillitis(exogenous wind-heat syndrome), which is safe and has good clinical application prospects.